Medical Coverage Policy | Non-Contact NonThermal Ultrasound Treatment for Wounds
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EFFECTIVE DATE: 12|01|2014
POLICY LAST UPDATED: 12|15|2015
OVERVIEW
Low-frequency ultrasound (US) in the kilohertz (KHz) range may improve wound healing.
MEDICAL CRITERIA
BlueCHiP for Medicare
Low frequency, non-contact, non-thermal ultrasound (MIST Therapy) is covered when one of the following
criteria is met:

Acute or chronic painful venous stasis ulcers, which are too painful for sharp or excisional debridement;

Acute or chronic arterial/ischemic ulcers, which are too painful for sharp or excisional debridement;

Diabetic or neuropathic ulcers;

Radiation injuries or ulcers;

Patients with wounds or ulcers with documented contraindications to sharp or excisional debridement;

Burns which are painful and/or have significant necrotic tissue;

Wounds that have not demonstrated signs of improvement after 30 days of documented standard wound
care;

Preparation of wound bed sites for application of bioengineered skin products or skin grafting.
Frequency/Duration
Per Medicare, low-frequency, non-contact, non-thermal ultrasound (MIST Therapy) must be provided 2-3
times per week to be considered “reasonable and necessary.” The length of individual treatments will vary per
wound size according to manufacturer recommendations.
Observable, documented improvements in the wound(s) should be evident after two (2) weeks or six (6)
treatments. Improvements would include documented reduction in pain, necrotic tissue, wound size. or
improved granulation tissue.
Per Medicare guidelines, the initial authorization will be for up to six (6) weeks or eighteen (18) treatments
with documented improvements of pain reduction, reduction in wound size, improved and increased
granulation tissue, or reduction in necrotic tissue. Continued treatments beyond eighteen (18) sessions per
episode of treatment requires re-review.
PRIOR AUTHORIZATION
BlueCHiP for Medicare
Prior authorization is required for BlueCHiP for Medicare only and is obtained via the online tool for
participating providers. See the Related Policies section.
Commercial Products
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MEDICAL COVERAGE POLICY | 1
Not applicable
POLICY STATEMENT
BlueCHiP for Medicare
Non-contact ultrasound treatment for wounds is covered for BlueCHiP for Medicare members who meet the
medical criteria as outlined below and is considered not medically necessary for all other indications as
there is insufficient peer-reviewed scientific literature that demonstrates that the procedure/service is
effective.
NOTE: Medicare policy is developed separately from Blue Cross & Blue Shield of Rhode Island (BCBSRI)
policy. Medicare policy incorporates consideration of governmental regulations from the Centers for
Medicare and Medicaid Services (CMS), such as national coverage determinations or local coverage
determinations. In addition to benefit differences, CMS may reach different conclusions regarding the
scientific evidence than does BCBSRI. Medicare and BCBSRI policies may differ. However, BlueCHiP for
Medicare members must be offered, at least, the same services that Medicare offers.
Commercial Products
Non-contact ultrasound treatment for wounds is considered not medically necessary as there is insufficient
peer-reviewed scientific literature that demonstrates that the procedure/service is effective.
COVERAGE
Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of
Coverage, or Subscriber Agreement for limitations of benefits/coverage for applicable surgery or when
services are not medically necessary.
BACKGROUND
Several devices are available, including the MIST Therapy® system, which delivers ultrasonic energy to
wounds via a saline mist without direct skin contact.
Ultrasound (US) is defined as a mechanical vibration above the upper threshold of human hearing (greater
than 20 KHz). US in the megahertz (MHz) range (1–3 MHz) has been used for the treatment of
musculoskeletal disorders, primarily by physical therapists. Although the exact mechanism underlying its
clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level,
including angiogenesis, leukocyte adhesion, growth factor and collagen production, and increases in
macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the
KHz range have also been examined. Low frequency US in this range may improve wound healing via the
production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.
The mechanical energy from US is typically transmitted to tissue through a coupling gel. Several high-intensity
US devices with contact probes are currently available for wound debridement. Recently, low-intensity US
devices have been developed that do not require use of a coupling gel or other direct contact. The MIST
Therapy™ System (Celleration, Eden Prairie, MN) delivers a saline mist to the wound with low-frequency US
(40 KHz). A second device, the Qoustic Wound Therapy System™ (Arobella Medical, Minnetonka, MN),
also uses sterile saline to deliver ultrasound energy (35 KHz) for wound debridement and irrigation.
Non-contact low-frequency ultrasound (US) in the kilohertz range is proposed to promote wound healing.
The available published evidence does not permit conclusions concerning the effect of non-contact US on
health outcomes compared to standard wound treatment. Well-designed, blinded studies that have adequate
numbers of patients and that include all relevant outcomes are needed to further evaluate the efficacy of this
treatment. Therefore, non-contact ultrasound treatment for wounds is considered not medically necessary.
For BlueCHiP for Medicare members, non-contact ultrasound treatment for wounds is considered medically
necessary when used for the indications listed in the medical criteria. There is no scientific literature to
500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699
(401) 274-4848 WWW.BCBSRI.COM
MEDICAL COVERAGE POLICY | 2
support the use of non-contact ultrasound treatment for other indications, therefore all other indications are
considered not medically necessary.
CODING
The following code is covered for BlueCHiP for Medicare only. It is considered not medically necessary for
Commercial products.
97610
RELATED POLICIES
Preauthorization via Web-Based Tool for Procedures
PUBLISHED
Provider Update, February 2016
Provider Update, January 2015
Provider Update, July 2013
Provider Update, May 2012
Provider Update, May 2011
Provider Update, July 2010
Provider Update, May 2010
REFERENCES
1. http://celleration.com/
2. Ennis WJ, Foremann P, Mozen N et al. Ultrasound therapy for recalcitrant diabetic foot ulcers:
results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound
Management;2005;51(8):24-39.
3. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency
ultrasound: the Mayo clinic experience, 2004-2006. Advanced Skin Wound Care;2007;20(4):221-6.
4. Kavros SJ, Liedl DA, Boon AJ et al. Expedited wound healing with noncontact, low-frequency
ultrasound therapy in chronic wounds: a retrospective analysis. Advanced Skin Wound
Care;2008;21(9):416-23.
5. Samies J, Gehling M. Acoustic pressure wound therapy for management of mixed partial- and fullthickness burns in a rural wound center. Ostomy Wound Management;2008;54(3):56-9.
6. Association for the Advancement of Wound Care (AAWC). Pressure Ulcer Guideline. Available
online at: www.guideline.gov
7. Association for the Advancement of Wound Care (AAWC). Venous Ulcer Guideline. Available
online at: www.guideline.gov
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This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical
judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate
and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific
benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases
medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the
member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation
agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge
are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue
Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.
500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699
(401) 274-4848 WWW.BCBSRI.COM
MEDICAL COVERAGE POLICY | 3